Clinical Trial

A phase 3 study of fixed dose combinations of fianlimab and cemiplimab versus relatlimab and nivolumab in participants with unresectable or metastatic melanoma

MOA: Fianlimab (REGN3767) is an anti-LAG-3 monoclonal antibody. Cemiplimab (REGN2810) is an anti-PD-1 antibody.

Key Eligibility Criteria:

• Histologically confirmed unresectable stage III and stage IV (metastatic) melanoma
  • Uveal, acral or mucosal melanoma are not eligible
• No prior systemic therapy for unresectable or metastatic melanoma
  • Pt with adjuvant/neoadjuvant therapy without PD during treatment are eligible if disease-free and treatment-free for over 6 months
  • No prior immune checkpoint inhibitor therapy other than anti-PD-1/ PD-L1
• Measurable disease per RECIST version 1.1
  • Previously irradiated lesions can be used as target lesions only if demonstrated to progress and no other target lesion is available
  • Cutaneous lesions are considered non-target lesions
• Patients must have known BRAFV600 status or submitted sample for assessment